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The Federal Circuit heard arguments July 20, 2012 in the
long-running dispute between The Association for Molecular
Pathology and Myriad Genetics, Inc. (Myriad), which the
Supreme Court returned to the Federal Circuit for reconsideration
in view of the Supreme Court's recent decision in Mayo
Collaborative Services v. PrometheusLaboratories,
Inc. In Prometheus, the Supreme Court held certain
claims to methods of determining a dosage of a drug were not patent
eligible subject matter, characterizing the claims as not
significantly more than a law of nature and as too broadly
preemptive of the natural law to be patent-eligible. The remand
reopened the question of patent eligibility of Myriad's claims
to isolated DNA encoding BRCA1 polypeptides and a method for
screening potential cancer therapeutics.
BRCA1 is a cancer susceptibility gene which can be inherited.
Women (and men) who inherit the gene have an increased chance of
certain cancers, in particular breast cancer. Both the American
Civil Liberties Union and the U.S. government are involved in the
case, both taking positions that certain of Myriad's patent
claims pre-empt important natural products and/or natural laws,
preventing free public access.
Myriad argued that the holding in Prometheus is
irrelevant to its isolated DNA claims. It further asserted that
pre-emption is not a separate test for subject matter patentability
but merely a proxy for the appropriate test. Myriad asserted that
patentability of the DNA claims is controlled by the Supreme
Court's 1980 decision in Diamond v. Chakrabarty, which
found genetically engineered oil-eating microbes patent eligible
and broadly held patent eligible anything under the sun that
required the hand of man. Myriad hung its subject matter
eligibility argument in favor of the method claim 20 on the
patent-eligibility of the transformed eukaryotic host cell
containing an altered BRCA1 gene.
Myriad also argued that method claim 20 was not properly before
the court because it was not part of the Association for Molecular
Pathology's (AMP) petition for certiorari. Judge Bryson pointed
out the court's task was not limited by what the petitioners
had included in their Supreme Court petition.
The AMP focused on "the stunning breadth" of the
product claims. Judge Lourie quickly dismissed this as a different
legal issue, one of scope of enablement and written description
under §112, rather than subject matter eligibility under
§101. Judge Moore was even sharper, quoting
Prometheus as saying that breadth is not relevant; she
advised AMP that its pre-emption argument "is a waste of time
and space." AMP quickly moved on to discuss method claim 20,
arguing that whether the method uses a product which may be patent
eligible should not make a difference to patent eligibility of the
method itself. Judge Moore was dubious, inquiring how that can be
if the transformed cell used in the method is not "found in
nature."
The U.S. limited its argument to the subject matter of claim 1,
isolated DNA encoding BRCA1 polypeptides, which the U.S.
characterized as isolated but otherwise unmodified. The U.S.
argument was also based on pre-emption. Although the U.S. indicated
that it did not want the court to make a special rule just for DNA,
it did argue that patent eligibility of a product should require
more than what is incidental to its isolation. This would move the
formerly bright line question for patent eligibility of a
product—"is it found in nature?"—to
"is it different from what is found in nature in a way that is
not merely incidental to its isolation?"
Judge Bryson asked how Myriad's isolated DNA claims were
different than claims to several presumably patent-ineligible
examples, including a baseball bat made out of a tree trunk, coal
mined from the earth, Michelangelo's David hewn from a block of
marble, and a kidney cut out of a body. Myriad distinguished these
examples by saying that it took substantial scientific ingenuity to
decide exactly where to cut to isolate the BRCA1 gene from a human
chromosome. Myriad did not point out that these examples involved
only physical changes, whereas DNA is chemically changed when it is
isolated from a chromosome. Past case law has consistently
recognized a chemical change as a hallmark of subject matter
eligibility.
Although the outcome of a case cannot necessarily be predicted
from the demeanor and comments of its judges at oral argument, it
appears that the Federal Circuit may reach the same outcome it had
previously. This time it may couch its decision differently, using
the language and concepts articulated by the Supreme Court in
Mayo.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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